FDA product code FAD: Stent, Ureteral
FAD is the FDA product code for stent, ureteral. It is a Class II device, regulated under 21 CFR 876.4620 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 122 510(k) submissions under FAD, 11 in the last five years, from 48 different applicants. The average 510(k) review took 154 days (median 106); 199 days on average over the last three years. FDA has posted 55 recalls for FAD devices, 13 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stent, Ureteral |
| Device class | Class II |
| Regulation | 21 CFR 876.4620 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FAD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 8 | 237 |
| 2018 | 9 | 225 |
| 2019 | 5 | 190 |
| 2020 | 1 | 216 |
| 2021 | 2 | 358 |
| 2022 | 5 | 236 |
| 2024 | 1 | 185 |
| 2025 | 4 | 166 |
| 2026 | 1 | 245 |
Compare with all 510(k) review times · Search every FAD clearance
Top FAD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Incorporated | 13 | 2019-04-23 |
| Surgitek | 9 | 1995-03-06 |
| Mentor Corp. | 8 | 1991-09-27 |
| Boston Scientific Corporation | 7 | 2025-04-15 |
| Coloplast Corp. | 7 | 2022-06-08 |
43 more applicants have FAD clearances. See the full list in Caduvo.
Most recent FAD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251890 | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Disposable Ureteral Stents | 2026-02-20 | 245 |
| K251469 | Cathegenix (Xiamen) Co., Ltd. | Endura Ureteral Stent and Stent Set | 2025-12-19 | 220 |
| K243039 | Alton (Shanghai) Medical Instruments Co., Ltd. | Ureteral Stents (AF-D series) | 2025-06-18 | 264 |
| K243830 | Shenzhen Trious Medical Technology Co., Ltd. | Disposable ureteral stent | 2025-05-14 | 152 |
| K250824 | Boston Scientific Corporation | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set | 2025-04-15 | 28 |
Recalls for FAD devices
55 product recalls in 15 recall events; 13 initiated in the last five years and 15 still open. Most recent: 2025-11-06.
| Year | Recalls |
|---|---|
| 2019 | 6 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 9 |
| 2025 | 4 |
Frequently asked questions
What is FDA product code FAD?
FAD is the FDA product code for stent, ureteral. It is a Class II device, regulated under 21 CFR 876.4620 and reviewed by the Gastroenterology and Urology panel.
What device class is FAD?
Class II, regulation 21 CFR 876.4620. Typical premarket route: 510(k).
How long does a 510(k) take for product code FAD?
Across 122 cleared submissions the average was 154 days from receipt to decision (median 106).
Which companies have the most FAD clearances?
Cook Incorporated (13); Surgitek (9); Mentor Corp. (8); Boston Scientific Corporation (7); Coloplast Corp. (7).
Have FAD devices been recalled?
Yes: 55 product recalls across 15 recall events; the most recent began 2025-11-06.
Next steps
- Run an FDA pathway report with predicate devices for product code FAD
- Run a recall and safety report across every FAD manufacturer
- Watch product code FAD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times